The AP (2/20, Perrone) reports that, according to the Food and Drug Administration, “three patients taking a Genentech drug,” Raptiva, “are believed to have died of a rare brain infection,” progressive multifocal leukoencephalopathy (PML), “a known risk with the skin-clearing treatment.” On Feb. 19, the agency “confirmed three cases and a possible fourth of” PML, “which causes swelling of the brain and is usually fatal. Notably, “the FDA announcement came the same day that European Union regulators recommended a ban on marketing the drug.”
The Wall Street Journal (2/20, Whalen, Dooren) reports that the European Medicines Agency said that Raptiva’s “risks now outweigh its benefits.” In October Raptiva’s label “was revised to highlight the risks of life-threatening infections, including PML, after one case of PML was seen.”
According to Bloomberg News (2/20, Olmos, Larkin), the FDA “said it’s reviewing the new information and ‘will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits.'” Meanwhile, “Genentech is ‘working diligently with the FDA to put the right plans in place that will help protect patient safety,’ said Tara Cooper, a spokeswoman for Genentech.” The San Francisco Business Times (2/19, Leuty) and the Los Angeles Times (2/19) “Booster Shots” blog also covered this story.
From the American Association for Justice news release.